The Antiplatelet and Immune Response Trial

Inclusion criteria

• Healthy male subjects, or female subjects not of childbearing potential (either surgically sterile or post menopausal)
• Age between 18 and 65 years inclusive
• Non smokers
• Body mass index (BMI) between 18 and 28 kg/m2 inclusive, with a body weight between 60-100 kg
• Subjects are to be in good health as determined by a medical history, physical examination, vital signs and clinical laboratory test results including renal and liver function and full blood count
• Subjects have given their informed consent before any trial-related activity

Exclusion criteria

• In the opinion of the investigator, subjects with, or a history of, cancer, diabetes or clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, haematological, dermatological, neurological, psychiatric, or other major disorders
• Subjects with a history of significant multiple drug allergies or with a known allergy to the study drugs or a medicine chemically related to the trial product
• Subjects who have had a clinically significant illness within 4 weeks of dosing
• Subjects taking regular medicines including NSAIDs, antibiotics, aspirin or anticoagulant therapy
• Any clinically significant abnormal laboratory test results at screening
• Subjects who have a supine blood pressure at screening, after resting for 5 minutes, higher than 150/90 mmHg or lower than 105/65 mmHg
• Subjects who have a supine heart rate at screening, after resting for 5 minutes, outside the range of 50-100 beats/min
• Subjects who have received any prescribed systemic or topical medication within two weeks prior to the start of dosing. Limited use of paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs) prior to the initiation of the study will not necessarily require exclusion unless there is an ongoing requirement for these medications.
• Subjects who have received an investigational medicinal product within the previous four months (new chemical entity) or three months (licensed product) or subjects who have received a vaccine within three months preceding the start of dosing
• Subjects who have donated any blood or plasma in the month preceding the start of dosing
• Subjects who have a history of alcohol or drug abuse
• Subjects with mental incapacity or language barriers which preclude adequate understanding
• Subjects with a contraindication to ticagrelor (as listed in the SmPC - hypersensitivity to the active substance or any of its excipients, active pathological bleeding, history of intracranial hemorrhage, moderate to severe hepatic impairment and co-administration with strong CYP3A4 inhibitors)
• Subjects with a contraindication to clopidogrel (as listed in the SmPC - hypersensitivity to the active substance or any of its excipients, severe hepatic impairment, active pathological bleeding such as peptic ulcer or intracranial haemorrhage)